UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`COALITION FOR AFFORDABLE DRUGS VII LLC,
`Petitioner
`
`v.
`
`HORIZON PHARMA USA, INC.,
`Patent Owner
`______________
`
`Case No. IPR2015-01718
`Patent No. 8,945,621
`______________
`
`MANDATORY NOTICES
`37 C.F.R. § 42.8
`
`
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`COALITION FOR AFFORDABLE DRUGS VII LLC,
`Petitioner
`
`v.
`
`HORIZON PHARMA USA, INC.,
`Patent Owner
`______________
`
`Case No. IPR2015-01718
`Patent No. 8,945,621
`______________
`
`MANDATORY NOTICES
`37 C.F.R. § 42.8
`
`
`
`Pursuant to 37 C.F.R. § 42.8, the real parties-in-interest for this proceeding
`
`Case No. IPR2015-01718
`Patent No. 8,945,621
`
`
`
`
`hereby submit the following mandatory notices in response to the Petition for Inter
`
`Partes Review of U.S. Patent No. 8,945,621 (“the ’621 patent”), case number
`
`IPR2015-01718.
`
`REAL PARTY-IN-INTEREST (37 C.F.R. § 42.8(b)(1))
`
`The real parties-in-interest are:
`
`Pozen Inc.;
`
`Horizon Pharma, Inc., a corporation organized and existing under the laws
`
`of the State of Delaware having its principal place of business at 520 Lake Cook
`
`Road, Suite 520, Deerfield, Illinois, 60015, which is wholly owned by;
`
`Horizon Pharma Finance S.á r.l., an entity organized and existing under the
`
`laws of Luxembourg, having its principal place of business at 19 Rue de Bitbourg,
`
`Luxembourg, which is wholly owned by;
`
`Horizon Pharma Capital Limited, a corporation organized and existing under
`
`the laws of Ireland, having its principal place of business at Connaught House, 1st
`
`Floor, 1 Burlington Road, Dublin 4, Ireland, which is wholly owned by;
`
`Horizon Pharma Holdings Limited, a corporation organized and existing
`
`under the laws of Ireland, having its principal place of business at Connaught
`
`House, 1st Floor, 1 Burlington Road, Dublin 4, Ireland, which is wholly owned by;
`
`2
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`
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`Horizon Pharma plc, a corporation organized and existing under the laws of
`
`Case No. IPR2015-01718
`Patent No. 8,945,621
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`Ireland, having its principal place of business at Connaught House, 1st Floor, 1
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`Burlington Road, Dublin 4, Ireland; and
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`Horizon Pharma USA, Inc., a corporation organized and existing under the
`
`laws of the State of Delaware having its principal place of business at 520 Lake
`
`Cook Road, Suite 520, Deerfield, Illinois, 60015, which is wholly owned by
`
`Horizon Pharma, Inc.
`
`Pozen Inc. (“Pozen”) is the licensor and patent owner of the ’621 patent.
`
`Horizon Pharma USA, Inc. (“Horizon”) is the exclusive licensee with the
`
`right to enforce and defend the ’621 patent in this IPR proceeding.
`
`Horizon obtained rights to the ’621 patent through an exclusive license
`
`agreement between patent owner Pozen and Horizon relating to the ’621 patent
`
`(“the License Agreement”), a redacted version of which is submitted with these
`
`mandatory notices.1 See Ex. 2001 (redacted version of the “License Agreement”).
`
`Under the License Agreement, Pozen granted Horizon an exclusive license in the
`
`Field of Use for the duration of the ’621 patent’s term, which includes the right to
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`sublicense, enforce, and defend the ’621 patent. See Ex. 2001 at §§ 1.43, 1.44, 7.1
`
`
`1 The redacted version of the License Agreement was previously submitted as a
`
`public document to the Securities and Exchange Commission by Horizon.
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`3
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`
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`9.6.1, 9.6.2, and 9.10.2, and Schedule 1.43. These rights specifically include the
`
`Case No. IPR2015-01718
`Patent No. 8,945,621
`
`right to defend reexamination proceedings. See Ex. 2001 § 9.6.2.
`
`Specifically, the License Agreement defines “Licensed Patents” as:
`
`1.43 “Licensed Patents” means: (a) the Patents set forth on
`
`Schedule 1.43, and any substitutions, divisions, continuations,
`
`continuations-in-part, reissues, renewals, registrations, confirmations,
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`re-examinations, or extensions of such Patents, (b) any Patents in the
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`Territory Controlled by POZEN or any of its Affiliates as of the
`
`Effective Date or during the Term that claim Inventions (including
`
`without limitation POZEN’s interest in Joint Inventions), and (c) all
`
`other Patents in the Territory Controlled by POZEN or any of its
`
`Affiliates as of the Effective Date or during the Term that are
`
`necessary or useful
`
`for
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`the Development, Manufacture or
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`Commercialization of a Product in the Territory. Notwithstanding
`
`anything in this Section 1.43 to the contrary, Licensed Patents shall
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`not include any Patents Controlled by POZEN with Valid Claims that
`
`do not cover any Product (e.g., any Patents with Valid Claims solely
`
`directed to any product containing acetyl salicylic acid).
`
`Ex. 2001 § 1.43.
`
`4
`
`
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`
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`The ’621 patent contains claims directed to, inter alia, methods of treatment
`
`Case No. IPR2015-01718
`Patent No. 8,945,621
`
`employing compositions including those claimed in U.S. Patent Appl. Nos.
`
`10/158,216 (U.S. Pat. No. 6,926,907) and 11/129,320 (now U.S. Pat. No.
`
`8,206,741), which are explicitly listed as “Licensed Patents” in Schedule 1.43 of
`
`the License Agreement. In addition, the ’621 patent is a “Patent[] in the Territory
`
`Controlled by POZEN or any of its Affiliates as of the Effective Date or during the
`
`Term that claim Inventions (including without limitation POZEN’s interest in Joint
`
`Inventions). Ex. 2001 § 1.43. “Inventions” as defined by the License Agreement
`
`“means any invention, discovery or Know-How that is conceived during the Term
`
`in the performance of activities undertaken pursuant to this Agreement by
`
`employees, agents, or independent contractors of either Party, its Affiliates or
`
`Sublicensees and is Controlled by such Party, Affiliates or Sublicensees.” Ex. 2001
`
`§ 1.37. Accordingly, the ‘621 patent falls within the scope of the “Licensed
`
`Patents.”
`
`
`
`The License Agreement also provides that Horizon is the exclusive licensee
`
`of the “Licensed Technology,” which includes the ’621 patent under the term
`
`“Licensed Patents.” Ex. 2001 § 1.44 (“‘Licensed Technology’ means the
`
`Licensed Patents and the Licensed Know-How”). The exclusive grant of rights to
`
`Horizon for the ’621 patent under the License Agreement is as follows:
`
`5
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`Case No. IPR2015-01718
`Patent No. 8,945,621
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`7.1 Licensed Technology. Subject to the terms and conditions of
`
`this Agreement, POZEN hereby grants to Licensee an exclusive
`
`(including with regard to POZEN and its Affiliates), royalty-bearing
`
`license, with the right to grant sublicenses as described in Section 7.3
`
`(Sublicenses), under the Licensed Technology to make, use, have
`
`made, sell, offer for sale, import and export Products in the Field of
`
`Use in the Territory. For the avoidance of doubt, Licensee shall have
`
`no license or other right under the Licensed Technology to make, use,
`
`have made, sell, offer for sale, import, and export any product
`
`containing acetyl salicylic acid (including salts and derivatives
`
`thereof).
`
`Ex. 2001 at § 7.1.
`
`The License Agreement further gives Horizon the rights to enforce and
`
`defend against challenges to the ’621 patent. These exclusive rights are set forth in
`
`section 9.6 of the License Agreement as follows:
`
`9.6 Enforcement of Licensed Patents.
`
`6
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`
`
`Case No. IPR2015-01718
`Patent No. 8,945,621
`
`9.6.1 Infringement by Third Parties. Licensee and POZEN will
`
`each, within [redacted]2 Business Days of learning of any alleged or
`
`threatened infringement of the Licensed Patents or Joint Patents,
`
`notify the other Party in writing. Licensee will have the first right, but
`
`not the obligation, to prosecute any such infringement. If Licensee
`
`does not commence an infringement action against the alleged or
`
`threatened infringement (i) within [redacted] days following the
`
`detection of the of alleged infringement, or (ii) [redacted] Business
`
`Days before the time limit, if any, set forth in appropriate laws and
`
`regulations for filing of such actions, whichever comes first, then
`
`Licensee will so notify POZEN promptly, and POZEN may
`
`commence litigation with respect to the alleged or threatened
`
`infringement at its own expense. . . .
`
`9.6.2 Challenge by Third Parties. Licensee and POZEN will each
`
`notify the other Party in writing within [redacted] Business Days of
`
`learning of any alleged or threatened opposition, reexamination
`
`request, action for declaratory judgment, nullity action, interference or
`
`2 These designations
`identify redacted material
`
`is not material
`
`that
`
`to
`
`demonstrating that Horizon is an exclusive licensee with all substantial rights to
`
`the ’621 patent.
`
`7
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`
`
`Case No. IPR2015-01718
`Patent No. 8,945,621
`
`other attack upon the validity, title or enforceability of the Licensed
`
`Patents or Joint Patents by a Third Party. Licensee will have the first
`
`right, but not the obligation, to defend any such challenge. If Licensee
`
`does not commence Diligent Efforts to defend against the alleged or
`
`threatened challenge (i) within [redacted] days following the detection
`
`of the alleged challenge, or (ii) [redacted] Business Days before the
`
`time limit, if any, set forth in appropriate laws and regulations for
`
`making a filing in defense of such a challenge, whichever comes first,
`
`then Licensee will so notify POZEN promptly, and POZEN may take
`
`action with respect to the alleged or threatened challenge at its own
`
`expense. . . .
`
`Ex. 2001 §§ 9.6.1, 9.6.2.
`
`As the foregoing terms of the License Agreement demonstrate, Horizon has
`
`obtained rights to the ’621 patent for purposes of this IPR through the License
`
`Agreement with Pozen, and is a real party-in-interest with standing for purposes of
`
`this Inter Partes Review proceeding.
`
`RELATED MATTERS (37 C.F.R. § 42.8(b)(2))
`
`Horizon Pharma, Inc. v. Actavis Labs. FL, Inc., 3:15-cv-03322 (D.N.J.);
`
`Horizon Pharma, Inc. v. Dr. Reddy’s Labs., Inc., 3:15-cv-03324 (D.N.J.);
`
`8
`
`
`
`
`Horizon Pharma, Inc. v. Lupin Ltd., 3:15-cv-03326 (D.N.J.); and Horizon Pharma,
`
`Case No. IPR2015-01718
`Patent No. 8,945,621
`
`Inc., v. Mylan Pharmas., Inc. 3:15-cv-03327 (D.N.J.).
`
`U.S. Patent Appl. No. 14/593,212 claims, or may claim, the benefit of
`
`priority to U.S. Provisional Application Nos. 61/310,525, filed on March 4, 2010;
`
`61/225,970, filed July 16, 2009; and 61/220,420, filed June 25, 2009, the same
`
`applications to which U.S. Patent No. 8,945,621 may claim priority.
`
`Patent Owner does not concede that any of these applications would affect,
`
`or be affected by, a decision in the present inter partes review of U.S. Patent No.
`
`8,945,621.
`
`LEAD AND BACK-UP COUNSEL (37 C.F.R. § 42.8(b)(3))
`
`Counsel for Horizon Pharma USA, Inc.:
`
`Lead Counsel
`Lauren L. Stevens, Ph.D.
`GLOBAL PATENT GROUP, LLC
`1005 N. Warson Road, Suite 404
`St. Louis, MO 63132
`Tel: (650) 387-3813
`Fax: (314) 685-2300
`lstevens@globalpatentgroup.com
`
`USPTO Reg. No. 36,691
`Back-up Counsel
`Ricardo Rodriguez
`COOLEY LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`Tel: (650) 843-5046
`Fax: (650) 843-7400
`
`Back-up Counsel
`Dennis Bennett
`GLOBAL PATENT GROUP, LLC
`1005 N. Warson Road, Suite 404
`St. Louis, MO 63132
`Tel: (314) 812-8018
`Fax: (314) 685-2300
`dennisbennett@globalpatentgroup.com
`
`USPTO Reg. No. 34,547
`Back-up Counsel
`Thomas A. Blinka, Ph. D.
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue, N.W,
`Suite 700
`
`9
`
`
`
`Case No. IPR2015-01718
`Patent No. 8,945,621
`
`Washington, DC 20004-2400
`Tel: (202) 842-7800
`Fax: (202) 842-7899
`tblinka@cooley.com
`
`USPTO Reg. No. 44,541
`
`Back-up Counsel
`Margaret J. Sampson, Ph.D.
`VINSON & ELKINS LLP
`2801 Via Fortuna
`Suite 100
`Austin, TX 78746-7568
`Tel +1.512.542.8569
`Fax +1.512.236.3264
`msampson@velaw.com
`
`USPTO Reg. No. 47,052
`
`Jeffrey S. Gritton
`VINSON & ELKINS LLP
`2801 Via Fortuna
`Suite 100
`Austin, TX 78746-7568
`Tel +1.512.542.8531
`Fax +1.512.236.3315
`jgritton@velaw.com
`
`USPTO Reg. No. 65,314
`
`
`
`10
`
`
`rr@cooley.com
`
`USPTO Reg. No. 40,789
`
`
`
`Counsel for Pozen Inc.:
`
`Lead Counsel
`Stephen M. Hash, Ph.D.
`VINSON & ELKINS LLP
`2801 Via Fortuna
`Suite 100
`Austin, TX 78746-7568
`Tel +1.512.542.8504
`Fax +1.512.236.3278
`shash@velaw.com
`
`USPTO Reg. No. 45,490
`
`
`
`
`
`Case No. IPR2015-01718
`Patent No. 8,945,621
`
`SERVICE INFORMATION (37 C.F.R. § 42.8(b)(4))
`
`Horizon and Pozen hereby consent to electronic service. Please direct all
`
`
`
`
`
`correspondence to: zIPR2015-01718@cooley.com,
`
`dennisbennett@globalpatentgroup.com, lstevens@globalpatentgroup.com,
`
`shash@velaw.com, msampson@velaw.com, and jgritton@velaw.com.
`
`
`
`Date: September 2, 2015
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/s/ Ricardo Rodriguez
`Ricardo Rodriguez
`Reg. No. 40,789
`Counsel for Patent Owner
`
`
`
`BY:
`
`
`
`
`120894587 v3
`
`11
`
`
`
`CERTIFICATION OF SERVICE UNDER 37 C.F.R. §§ 42.6(e), 42.105(a))
`
`I, Ricardo Rodriguez, hereby certify that on this 2nd day of September,
`
`Case No. IPR2015-01718
`Patent No. 8,945,621
`
`
`
`
`
`2015, the foregoing Patent Owner’s Mandatory Notices pursuant to 37 C.F.R. §
`
`42.8 was served electronically via email on the following:
`
`Amy E. LaValle
`alavalle@conleyrose.com
`
`Jerry C. Harris, Jr.
`jcharris@conleyrose.com
`
`Rodney B. Carroll
`rcarroll@conleyrose.com
`
`Conley Rose, P.C.
`5601 Granite Parkway, Suite 500
`Plano, Texas 75024
`
`
`
`
`
`Date: September 2, 2015
`
`
`/s/ Ricardo Rodriguez
`Ricardo Rodriguez
`Reg. No. 40,789
`Counsel for Patent Owner
`
`BY:
`
`
`
`
`
`
`
`
`120894587 v3
`
`12
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